Delivery of compositions to conduits of human or animal bodies is useful in multiple medical disciplines for various medical conditions. For example, delivery of compositions for the occlusion of conduits is useful in reproductive control and is the subject of U.S. patent application Ser. No. 11/065,886, and U.S. patent application Ser. No. 12/240,738, each of which is incorporated in its entirety herein. Over the last 50 years, the world has experienced the highest rates of population growth and the largest annual population increases recorded in history. Women account for over 50% of the world's population and play a critical role in family health, nutrition, and welfare. One of the most significant areas in need of attention and innovation in women's healthcare is that of contraception, where the reproductive aged woman is currently faced with sub-optimal alternatives.
Delivery of compositions to conduits of human or animal bodies is also useful in procedures that are involved with enhancing the fertility of human or animal bodies. For example, Gamete Intrafallopian Transfer (GIFT) uses eggs that have been removed from a female's ovaries, combined with washed sperm, and then both eggs and sperm are placed into the females' fallopian tube(s) through a small incision in her abdomen. The procedure is generally performed by laparoscopy. GIFT is an assisted reproductive technology that was introduced in 1984 that by-passes one of the normal functions of the fallopian tube, the pick-up of eggs released from the ovaries. Eggs and sperm are placed directly into the ampullary region of the fallopian tube, and fertilization and early embryo development occurs there, and the embryo is transported to and enters the uterine cavity. GIFT is performed using laparoscopic measures, or other invasive techniques that require surgical intervention or anesthetic procedures, which adds to the risk of the procedures.
Procedures are also performed in conduits of humans and animals to assess the physical condition of such conduits. For example, assessment of conduits such as arteries or veins are commonly performed in diagnosing and determining needed treatments related to cardiac, neural, kidney and vascular conditions. In assessing the fertility of humans or animals, procedures for determining fallopian patency are commonly performed. Such procedures may involve gas insufflation or radiation exposure, as is the case for hysterosalpingography (HSG), or laparoscopic procedures.
Gas insufflation was used for many years, and is a simple test to carry out and does not require a general anesthetic. An instrument is inserted into the canal of the cervix and carbon dioxide gas is introduced into the cavity of the uterus. The machine controlling the flow of carbon dioxide also records the pressure of the gas as it builds up in the uterus. If the fallopian tubes are blocked, there is an increase in pressure of the gas within the uterus. If at least one tube is open to the passage of gas, the initial rise in pressure is followed by a sudden reduction as the gas escapes out of the tubes and into the abdominal cavity. The results of the test are difficult to interpret and do not provide any information about the condition of the fallopian tubes other than that gas is able to pass through at least one fallopian tube. No data is provided about the structure of the tube, the extent of the diameter of the fallopian tube, or whether both tubes are patent. If the test fails, there is no information about the location or nature of the obstruction. The inaccuracy of the test has led it to be largely superseded by other tests.
Hysterosalpingography (HSG) involves a contrast dye inserted into the uterine cavity and viewing the structures revealed by fluoroscopy. The test is normally performed without general anesthetic. The contrast agent, generally a radiopaque dye, shows the structure of the uterus and fallopian tubes as the contrast agent fills the uterine cavity and exits the fallopian tubes, if possible. If the dye fails to enter the tubes this may indicate an obstruction or a temporary spasm of the tubes at this site. Sometimes the dye can be seen to enter the tubes, which then become distended owing to an obstruction at their outer ends. An HSG can identify the site of a tubal obstruction and can also show the presence of an irregularity in the shape of the cavity of the uterus. Discomfort to the patient and exposure to radiation required to view the structures under fluoroscopy are the primary concerns with this procedure.
Laparoscopic methods may also be used to detect patency of the fallopian tubes. A laparoscope is inserted into the abdominal cavity and the uterus, fallopian tubes and ovaries are visually inspected. Tubal patency is tested by injecting a contrast medium, such as, methylene blue dye into the uterus through the cervix. In anatomically normal fallopian tubes, the dye can be seen passing along them and escaping through the outer openings (fimbria) of the tubes. The procedure is an adjunctive procedure to a laparoscopy and requires general anesthesia for the patient.
Ectopic pregnancies result from a fertilized egg implanting in an area other than the uterus. About 1% of pregnancies are in an ectopic location with implantation not occurring inside of the womb, and of these 98% occur in the Fallopian tubes. In a typical ectopic pregnancy, the embryo adheres to the lining of the fallopian tube, and does not reach the uterus. The embryo burrows actively into the tubal lining. This burrowing may invade blood vessels and cause bleeding. The intratubal bleeding may expel the implantation out the distal end of the tubal. There is generally no inflammation of the tube in an ectopic pregnancy. The pain that may be present is caused by prostaglandins released at the implantation site, by distension of the tubal serosal lining or by free blood in the peritoneal cavity, which is a local irritant. The bleeding might be heavy enough to threaten the health or life of the woman, but this is generally seen when there has been a delay in diagnosis, but sometimes, especially if the implantation is in the proximal tube (just before it enters the uterus), it may invade into a large blood vessel causing heavy bleeding. About 50% of ectopic pregnancies resolve without treatment. The condition may be treated using intramuscular or intravenous methotrexate, but surgical intervention is often required when the Fallopian tube has ruptured or is in danger of doing so. This intervention may be laparoscopic or by laparotomy. It is common practice to check the status of the fallopian tube after an ectopic pregnancy.
An ideal system for delivery of compositions to conduits, such as fallopian tubes, or examination of such conduits to diagnose or assess structural conditions, is one that would provide an immediate diagnosis and allow for concurrent treatment, that is non-surgical, easy to deliver and is an office-based solution that does not require anesthesia or special equipment not available in an office setting. None of the current options meets these requirements. While the currently available compositions and methods represent a significant advancement in the art, further improvements would be desirable to provide safe, effective and non-surgical devices, compositions, and methods for delivery of compositions to conduits and for treatment and/or diagnosis of conduits. It would be beneficial if these devices, compositions and methods provided an immediate effect or answer, non-surgical, easy to deliver, office-based solution that does not require anesthesia or specialized equipment not available in an office setting. What is needed are methods, devices and compositions that have these characteristics for the delivery of compositions to conduits and for the treatment and/or diagnosis of conduits, such as one or more fallopian tubes.